JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S

JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.

On 3/16/23, recall notices were distributed to customers who were told the following: Plate replacement: If the issue occurs, the surgeon should proceed as follows: 1- Unscrew the Plate screw of the cage with the screwdriver, 2- Scrap the current plate assembly, 3- Use a new set of pre-assembled plate/screw (a minimum of 2 sets of pre-assembled plates/screws per size are part of the device listing). The cages are to be used with the corresponding plate or higher plate which means that a plate with the same height than the cage can be used but also a plate with higher height. 4- In the case of 0-degree and 8-degree cages, a pre-assembled plate/screw is not mandatory as described in the surgical technique Acknowledge receipt of this letter by emailing to [email protected] Discontinue use and return any product on hand. Customers with questions can contact firm at 949-313-6400 Monday through Friday, 8:00am to 5:00pm, Pacific, or email at [email protected]